A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn’s Disease

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Teva Branded Pharmaceutical Products R&D LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

Trial duration

29 Jun 2023 → ongoing

Decision date (initial)

2024-09-29

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Teva Branded Pharmaceutical Products R&D LLC

External identifiers

EU CT number

2024-515027-11-00

EudraCT number

2022-002593-89

ClinicalTrials.gov

NCT05668013

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Pharmacokinetic, Others, Safety

The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV 48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult patients with IBD (moderate to severe UC or CD) as assessed by maintenance of clinical remission (UC) and endoscopic response (CD) at end of maintenance period (EOM).

Secondary objectives 2

1. 1. A secondary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV 48574 sc administered Q4W in adult patients with IBD (moderate to severe UC or CD) as assessed by multiple standard measures at EOM.
2. 2. A secondary objective of the study is to evaluate the immunogenicity of 2 different maintenance dose regimens of TEV-48574 sc administered Q4W in adult patients with IBD (moderate to severe UC or CD).

Conditions and MedDRA coding

Crohn’s disease

Study design 4 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 2

1. 1.Maintenance Period: Adults of male and female sex (without restrictions based on gender) who achieved clinical response and/or clinical remission at week 14 of TV48574-IMM-20036 (the 14-week DRF study) or in the re-induction period of this study. OLE Period: Adults of male and female sex (without restrictions based on gender) who have clinical response and/or clinical remission at week 44 of the maintenance period of this study.
2. 2. Re-induction Period: Adults of male and female sex (without restrictions based on gender) who did not achieve clinical response and/or clinical remission at week 14 of the TV48574-IMM-20036 DRF study

Exclusion criteria 4

1. 1.Patients who discontinued the DRF study before scheduled week 14 visit (any reason including lack of efficacy, safety, or personal reasons).
2. 2. The patient has any concomitant conditions or treatments that could interfere with study conduct, influence the interpretation of study observations/results, or put the patient at increased risk during the study as judged by the investigator and/or the clinical study physician.
3. 3. Patient anticipates requiring major surgery during this study.
4. 4. The patient is currently pregnant or lactating or is planning to become pregnant or to lactate during the study or for at least 50 days after administration of the last dose of IMP in case of early termination. Any woman becoming pregnant during the study will be withdrawn from the study.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. 1.Clinical remission based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of ≤2 points defined by a stool frequency subscore of 0 or 1, rectal bleeding subscore of 0, and an endoscopic subscore of 0 or 1, where a score of 1 does not include “friability” at week 44 in patients with UC
2. 2. Endoscopic response, defined as a decrease in Simple Endoscopic Score for Crohn’s Disease (SES-CD) of at least 50% from dose-range finding (DRF) study baseline at week 44 in patients with CD

Secondary endpoints 12

1. 1. Clinical response, based on modified (9-point rectal bleeding, stool frequency, and endoscopy) Mayo score of at least 2 points AND at least a 30% reduction from DRF study baseline with either a decrease in rectal bleeding subscore of at least 1 or an absolute rectal bleeding subscore of less than or equal to 1 at week 44 in patients with UC
2. 2. Endoscopic improvement from DRF study baseline based on Mayo endoscopic subscore of 0 or 1 at week 44 in patients with UC
3. 3. Endoscopic remission based on Mayo endoscopic subscore of 0 at week 44 in patients with UC
4. 4. Corticosteroid-free clinical remission based on the modified Mayo score at week 44, defined by clinical remission (see primary endpoint) and corticosteroid free for ≥12 weeks preceding week 44, in patients with UC.
5. 5. Clinical response based on Crohn’s Disease Activity Index (CDAI): ≥100-point decrease in CDAI score from DRF study baseline in patients with CD at week 44
6. 6. Clinical remission based on CDAI score <150 at week 44 in patients with CD
7. 7. Corticosteroid-free endoscopic response based on SES-CD at week 44, defined by endoscopic response (see primary endpoint) and corticosteroid-free for ≥12 weeks preceding week 44, in patients with CD
8. 8. Corticosteroid-free clinical remission based on CDAI at week 44, defined by a CDAI score of <150 points and corticosteroid-free for ≥12 weeks preceding week 44, in patients with CD
9. 9. Adverse events Adverse events can include any of the following clinically significant changes in clinical laboratory test results (serum chemistry, hematology, and urinalysis), vital signs measurements (blood pressure, pulse rate, body temperature, and respiratory rate), 12-lead electrocardiogram (ECG), and injection site reactions
10. 10. Patients who stopped the investigational medicinal product due to adverse events
11. 11. Treatment-emergent anti-drug antibody (ADA)
12. 12. Neutralizing ADA in ADA positive patients throughout the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Teva Branded Pharmaceutical Products R&D LLC

Sponsor organisation

Teva Branded Pharmaceutical Products R&D LLC

Address

145 Brandywine Parkway

City

West Chester

Postcode

19380-4245

Country

United States

Scientific contact point

Organisation

Teva Branded Pharmaceutical Products R&D LLC

Contact name

Medical Information

Public contact point

Organisation

Teva Branded Pharmaceutical Products R&D LLC

Contact name

Medical Information

Third parties 13

Locations

10 EU/EEA countries · 58 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 120 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications